Browse Device Recalls
22 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 22 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 22 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 3, 2026 | OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria ide... | Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A l... | Class II | Oxoid Australia Pty Limited |
| Feb 1, 2021 | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 | Due to software defect, under certain assay parameters, false Vitamin D results may be reported. ... | Class II | Thermo Fisher Scientific |
| Apr 29, 2020 | Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Cat... | Product was not irradiated; therefore, they are not sterile and do not meet product specification. | Class II | Thermo Fisher Scientific (Monterrey) |
| Jul 18, 2019 | Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, ... | Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... | Class II | Thermo Fisher Scientific (Monterrey) |
| Jul 18, 2019 | Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen cont... | Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... | Class II | Thermo Fisher Scientific (Monterrey) |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bat... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model N... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| May 19, 2017 | Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 0084527500... | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, li... | Class II | Fisher Diagnostics |
| May 19, 2017 | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determ... | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, li... | Class II | Fisher Diagnostics |
| Mar 17, 2016 | enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec... | The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l... | Class II | Ortho-Clinical Diagnostics |
| Dec 6, 2013 | Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml... | Reports that the product is not performing as expected. In house testing showed no staining on br... | Class II | Lab Vision Corporation |
| Oct 29, 2013 | MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)... | Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet ... | Class III | Thermofisher Scientive |
| Oct 16, 2013 | Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog... | Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot ... | Class II | Microgenics Corp |
| Nov 29, 2012 | CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381,... | Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Aug 21, 2012 | Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0... | The firm is recalling the product due to some cartridges may contain individual discs that are no... | Class II | Remel Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.